Sustaining Edge

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others. This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Investing in Process Improvement

During these challenging economic times, many companies are under pressure to cut costs in response to lower revenues and decreased margins. Many are cutting costs haphazardly, for example letting people go (and the institutional knowledge with it) when they should be streamlining their business processes to become more efficient, enhance results, and achieve sustainable success.

When times are good, many companies create a “surplus to process requirements” based on immediate needs. More inspection and non-value-added steps that result from high volume needs may not work in a reduced economy. There is no room for redundancy and cost cutting must be focused on waste reduction. Organizations need to streamline costs yet still provide optimal value through exceptional product or service quality.

Investing in process improvement while cutting costs may seem counterintuitive, however by studying how the process is producing the desired output you can scale back and still meet your requirements and the customers needs. A well designed and executed improvement effort will always identify non-value-added activities for elimination, where those dollars saved can be used for other purposes and positively impact customer satisfaction. On the flip side, rash decision making and cost cutting can produce a detrimental effect on your business disappointing customers and reducing your revenues.

How can your organization improve processes to face the economic downturn?

Identify the critical processes that produce the most value to your customers.
Communicate with your customers and involve them with defining (or redefining) their needs and wants and adjust your outputs accordingly.
Understand how your processes work. Dissect your processes and identify the critical variables, inputs into outputs. For example, people, material, methods, environment, hardware, software.
Establish and/or review the criteria used for the operation of your processes For example, performance metrics related to process outputs, key variables, documentation used, or not used effectively, training effectiveness or lack of training validation.
Use Lean tools and methods to aggressively eliminate waste in these processes. For example, 5S, value steam mapping, error proofing, kaizen, visual management or kanban.
Follow-up with Six Sigma tools to minimize process variation and improve the accuracy and predictability of your processes. For example, process mapping, QFD, FMEA, control charts and SPC methods.
Make process improvement a constant within your organization. Reward people for their ideas and ensure they provide the highest quality product and service. This requires leadership determination and organizational commitment.

In the proactive mode, the organization that recognizes the need to continually improve its processes to meet the challenges of the future, even in poor economic times is successful. Successful organizations understand this – let it work for you and your organization.

We can help your organization produce tangible improvement results, Contact us.

Study Finds Baldrige Criteria Results in Cost Savings

During the years 2007 through 2010, there were 322 applications for the Malcolm Baldrige National Quality Award. These 322 applications were from 273 firms and organizations; the 49 additional applications were repeat applications from some of the 273 firms and organizations. The 273 firms and organizations that applied for the Award from 2007 through 2010 were asked by the Program Office to participate in a study of the benefits they received through the Award application process.

Specifically, each firm or organization was asked to complete a Web-based survey instrument. A total of 45 firms and organizations responded to the survey request-a response rate of 16.5%-and the results from an evaluation analysis based on those responses are discussed in this report.

Using a counterfactual evaluation method, three categories of social benefits have been quantified from the responses of 45 Award applicants to a Web-based survey. These categories
are:

the counterfactual cost savings of the applicants because it was not necessary for them to incur the investment costs to achieve on their own the same level of benefits from their performance excellence strategies as they realized from the availability of the publicly funded Baldrige Performance Excellence Program,
the gains to consumers from greater satisfaction from higher quality products because the Baldrige Criteria were available and used,
the gains to the economy from saving scarce resources (because successful performance excellence strategies not only enable higher quality products or services but also lower the costs of providing them) because the Baldrige Criteria were available and used.

The benefit-to-cost ratio of 820-to-1-using only the benefits for the surveyed group of applicants for the National Quality Award since 2006 but using all of the social costs of the Baldrige Program-certainly supports the belief that the Baldrige Program creates great value for the U.S. economy.

The Baldrige Performance Excellence Program, with the imprimatur of national leadership and a prominent national award presented by the President, creates great value that could not be
replicated by private sector actions alone.

The entire report is available in PDF at the NIST website.

Audit Defintitions According to ISO 19011:2011

The ISO 19011:2011 audit guidance standard has revised audit definitions, expanded related notes, and added new definitions. Some examples of these changes are described below.

The definition of audit: a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Its revised note clarifies that the purpose of an internal audit may be to confirm the effectiveness of the management system or to obtain information for the improvement of the management system. The note adds that in a small organization, independence can be shown by freedom from responsibility for the activity being audited or freedom from bias and conflict of interest.

The definition of audit findings: the results of the evaluation of the collected audit evidence against audit criteria. A note states audit findings indicate conformity or nonconformity. A new note under audit findings clarifies that findings can lead to the identification of opportunities for improvement or recording good practices. Another new note says if the audit criteria are selected from legal or other requirements, the audit finding is termed compliance or non-compliance (instead of conformity or nonconformity).

The definition of audit client: the organization or person requesting an audit. Its note states that in the case of an internal audit, the audit client can also be the auditee or the person managing the audit program. The note also says requests for external audit can come from sources such as regulators, contracting parties, or potential clients.

The definition of competence: the ability to apply knowledge and skills to achieve intended results. The related note states that ability implies the appropriate application of personal behavior during the audit process.

The new definition for guide: a person appointed by the auditee to assist the audit team. The new definition for observer is: a person who accompanies the audit team but does not audit. Its notes add that an observer is not a part of the audit team and does not influence or interfere with the conduct of the audit. It says an observer can be from the auditee, a regulator, or other interested party who witnesses the audit.

The new definition for management system: a system to establish policy and objectives and to achieve those objectives. The related note states a management system of an organization can include different management systems, such as a quality management system, a financial management system, or an environmental management system.

Purchase ISO 9001:2011 Guidelines for auditing management systems at the ANSI Standards Store.

In the News

Personal Health Data Protected by New ISO Standard

ISO has published a new technical specification which will increase protection of personal health information processed, stored and transferred by computer systems for subsequent use by clinicians and others in healthcare organizations. ISO/TS 14265:2011, Health informatics – Classification of purposes for processing personal health information, defines a set of high-level categories of purposes for which such personal health information can be processed.

ISO/TS 14265:2011, provides a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organizations, regional health authorities, jurisdiction countries) as an aid to the consistent management of information in the delivery of healthcare services and for the communication of electronic health records across organizational and jurisdictional boundaries.

For more information see the ISO News Page.

AIAG PFMEA Fourth Edition – Still the Best

The AIAG FMEA manual defines FMEA as “an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process. FMEAs are an effective tool to quantify risk so it can be analyzed, prioritized, mitigated, or eliminated.” FMEAs can be applied in all types of organizations, including manufacturing and service.

Risk is generally quantified by using a risk priority number (RPN), which is calculated by multiplying ratings for severity (S) of problem by likelihood of occurrence (O) by likelihood of detection (D), or S × O × D = RPN. Use of arbitrary thresholds, for example, RPN > 40, is not recommended. Organizations should be working the highest priority risks regardless of the rating criteria or values. High severity ratings should always be addressed.

The FMEA manual indicates that the FMEA scope “establishes the boundary of the FMEA analysis.” The scope can be system, subsystem, or component. A system consists of many subsystems, which consist of many components. The links and interactions among parts within the scope, as well as with other subsystems or systems, also must be addressed.

Purchase PFMEA Fourth Edition at the AIAG Store.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for these courses and customized training to fit your specific needs. We offer group discounts.

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ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Email: wtighe@sustainingedge.com

Phone: 888-572-9642 toll free

Website: http://www.sustainingedge.com

Supplier Requirements to the Aerospace and Defense Industry

Walter — Sun, 29 Jan 2012 01:35:41 +0000

We just attended the Aerospace and Defense Requirements Conference at the Phoenix Convention Center this week. In our home state of Arizona, we have many suppliers providing products and services to the Aerospace and Defense industry. This conference was sponsored by many prime manufacturers such as Honeywell, Boeing, and Raytheon; including being presented by the Arizona Technology Council, where Sustaining Edge Solutions is a member company.

The primary goal of this conference was to allow those who attended the opportunity to hear firsthand what type of supplier requirements it takes to become a preferred supplier. A common theme from BAE Systems, Northrop Grumman, Boeing and other presenters was the need, NO the Requirement that all suppliers must have an effective Quality Management System and Certification to ISO 9001/AS9100.

The following are notes we quickly wrote as the speakers presented:

Must have ISO/AS certification, a strong Quality Management System.
Just-in-time supply systems, including a 100% on-time delivery.
Zero parts per million – supplier expectation.
Cost, quality and schedule imperative for all suppliers
42% of Boeing Defense, Space and Security revenue is subcontracted.
Deliver value and solutions – must be customer focused.
Have an up-to-date website. “Let people know who you are.”
Register for online RFP applications
Know your customer and potential customers quality requirements.
Improve affordability and efficiency through Lean Operations.

What’s the take away here? Supplier opportunities do exist according to all the presenters we heard. At a minimum, if your company is not certified to the ISO 9001/AS9100 standard, you won’t be considered. Also, having an effective lean manufacturing program focus on quality, cost, and schedule is highly desirable.

Question: Has certification to ISO 9001 or AS9100 helped your organizational growth? Have you found it to be a prerequisite to become a supplier to major Aviation, Space and Defense customers?

Let us know!!

Executive Team Involved with Your QMS?

Walter — Tue, 03 Jan 2012 22:00:14 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business January 2012

This Month

* Your Executive Team Involved in QMS?

* Economy Chief Concern in 2012

* Global Impact of ISO Standards

* In the News

* Training Courses

Aerospace, Aviation and Defense Requirements Conference

January 25-26, 2012 Phoenix Convention Center Phoenix, AZ

Lean and Six Sigma Conference

February 27-28, 2012

Phoenix, AZ

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If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Celebrating our 10th Year (2002-2012) Improving Performance!

We are very proud in celebrating our 10th anniversary of business improving operational and quality management systems performance. It has been an extremely rewarding experience for us and we look forward to this New Year and Beyond. Our sincere thanks to all our clients and newsletter readers.

Executive Management Team Involved with Your Quality System?

Note: Though this article references 21 CFR Part 820, it is applicable to any company that is striving for more quality-system input and involvement from management.

Many of us heard of the recent FDA decision to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area.

According to an article written by Christine Park, published in GxP Lifeline while there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems:

“Failure of management with executive responsibility to adequately ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, the Quality Policy has not been established by any member of executive management…”

“Failure to establish and maintain procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer’s established quality policy and objectives as required by 21 CFR 820.20(c).”

These examples are obviously blatant and send a strong message: Now is the time to step back and re-evaluate the role your executive management team is playing in your own quality system.

21 CFR 820 defines management with executive responsibility as “those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.” What does this really mean and how can you as a Quality Professional help your executive management team meet these requirements in the course of every-day business practice?

In most organizations, the company quality policy is derived by the executive management team. The quality policy is then widely distributed to all employees with appropriate explanation to understand the intent and purpose of the policy. Additionally, the quality policy must be measurable and reviewed for adequacy as part of the management review.

The responsibilities for management with executive responsibility can be distributed into four key areas of focus:

Core competencies. The executive management team is responsible and accountable for providing clear direction and a definition of the business structure and its related vision. The documentation of core competencies and skill sets should be integrated into the overall business plan and managed by the executive team. The quality manual can effectively achieve this task when written and implemented as a roadmap to compliance.

Internal Audits. We live in a world of matrixed organizations and operations. The silo approach to business process and quality system management is not an effective means of achieving the overall business and quality plan. The internal auditors must look at the interfaces between processes as well as the individual function or process. The data from internal audits should be presented to executive management in a format that demonstrates the effectiveness of the quality system structure and business process.

Just because the number of non-conformances decreases from audit to audit does not mean the internal audit program is good or the quality system is effective. The data analysis should look across the core competencies, functions, and processes to determine any potential systemic issues. Question: Is your organization quantifying the postive results (your investment return) of your internal audits to show executive management the payback?

Meaningful Metrics. The most common approach to keeping executive management involved is through the Quality Management System Review. These management reviews are regularly scheduled with the executive management team based on the organization’s needs and requirements. While the primary focus of these reviews is to review quality performance, it is most effective to present the information based on its overall impact to the business.

This equates to moving beyond the minimum required inputs based on the standard your company is registered. The value of this meeting is to present information that has the biggest impact on the business from a quality and/or financial perspective. Each chart presented should tell a story and speak for itself. This approach sets a stronger foundation for risk based decisions.

Risk Management Process.The executive management team makes risk-based decisions as a part of their routine business activities. Risk management extends beyond the product risk preparations and analyses as required by the regulations.

Risk management also covers process and project risk. In most companies, resources are limited and priorities must be evaluated and set to drive the business to success and high customer satisfaction. There are many tools available to evaluate risk, prioritize activities, and reduce the potential for failure. These tools should be included in the everyday decision making process for the management team.

When the quality management system and the business plan are integrated at the executive level there is a strong foundation for the organization to make good decisions-business decisions as well as product quality decisions.

Further points to consider:

How effective is your management review process? Do you provide data for data’s sake or are you providing appropriate analysis to help the executives be more aware of product and process quality so that they can make better business decisions?
How does your organization use your quality manual? Is it a roadmap providing guidance for compliance to regulation and business process? Or is it just another book on the shelf?
Are you sure that you could provide adequate evidence that the executive management team is actively involved with the quality system?

Take a few minutes and evaluate your own system now. It may save you the agony of a warning letter in the future. Quality is not hard-it’s just good business.

Economy Chief Concern in 2012 for Manufacturers

While 66 percent of manufacturers expect to experience revenue growth in 2012, many say the recovering economy will remain a major hurdle to operations, according to a recent ASQ survey.

Nearly 1,600 manufacturing professionals from around the world responded to ASQ’s 2012 Manufacturing Outlook Survey, which was conducted online from Oct. 17 through Nov. 4. Respondents represent the aerospace, automotive, food, medical device, pharmaceutical and utility industries, among others.

According to the survey results, more than 70 percent of respondents say they experienced revenue growth in 2011. In ASQ’s 2011 Manufacturing Outlook Survey conducted in late 2010, 67 percent had hoped to experience revenue growth in 2011.

Despite the outlook regarding revenue, manufacturers continue to be wary of the global economy, citing the housing market and fears of a double-dip recession.

In addition to fears of the world economy, manufacturers say the lack of a qualified workforce is inhibiting their ability to grow. According to the survey results, 44 percent of respondents say finding qualified applicants is the biggest hurdle to filling vacant positions, while 27 percent say budget is a biggest hurdle to filling open positions. Twenty-three percent claim time-and the lack thereof-is the biggest hiring hurdle.

Retiring employees pose minimal effect.

Survey results show few manufacturers think their company will be adversely affected by retirements in 2012. On a scale of one to 10, where one is “very unlikely” and 10 is “very likely,” nearly 68 percent of respondents said retirements were “unlikely” to affect their business, including 26 percent who said retirements were “very unlikely” to affect the organization. Only 9 percent said retirements were “very likely” to affect the business.

“While many manufacturers are showing improvement and experiencing revenue growth, there remains clear hurdles facing these businesses,” said ASQ CEO Paul Borawski. “Even though companies say retiring baby boomers aren’t adversely affecting their businesses, finding qualified employees is still a concern-one that can affect businesses in this global economy-as retiring employees often leave with a wealth of knowledge not easily replaced.”

Global Impact of ISO Standards Application

Beginning with the first publication of ISO 9000 in 1987, the impact of ISO on organizational practices and world trade has been tremendous. The development of management system approaches to many specific sectors has happened as well. Some of these you may not be aware of include:

ISO 10002:2004 Quality management – Customer Satisfaction – Guidelines for complaints handling in organizations. ISO 10002 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement.

ISO 10003:2007 Quality Management – Customer Satisfaction Guidelines for Dispute Resolution External to Organizations. ISO 10003 provides guidance for an organization to plan, design, develop, operate, maintain, and improve an effective and efficient dispute-resolution process. It is applicable to complaints relating to the organization’s products intended for, or required by, customers, the complaints-handling process, or dispute-resolution process

ISO/TS 10004:2010 Quality management – Customer satisfaction – Guidelines for monitoring and measuring. ISO/TS 10004 provides guidance in defining and implementing processes to monitor and measure customer satisfaction. It is intended for use by organizations regardless of type, size, or product provided.

ISO 50001:2011 Energy Management (planned). ISO 50001 will help organizations to improve their energy performance, increase energy efficiency, and reduce climate change impacts. It will establish a framework for industrial plants, commercial facilities or entire organizations to manage energy.

ISO 22000:2005 Food safety management systems. ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

IWA 1:2005 Health Care quality management systems — Guidelines for process improvements in health service organizations. IWA 1 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.

ISO 31000:2009 Risk management. ISO 31000 provides principles and generic guidelines on risk management. The standard can be applied to any type of risk, whether having positive or negative consequences.

ISO 20000-1:2011 Service management system requirements. ISO 20000-1 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain, and improve an SMS.

ISO has developed over 18,500 International Standards on a variety of subjects and some 1,100 new ISO standards are published every year. The full range of technical fields can be seen from the listing International Standards. Users can browse that listing to find bibliographic information on each standard and, in many cases, a brief abstract.

Click here to browse all ISO Standards.

In the News

Become a Baldrige Examiner

Deadline Friday, Jan 13th. Each year, the Baldrige Performance Excellence Program seeks applicants for its Board of Examiners. The board supports and evaluates the performance improvement of all types of organizations-businesses, schools, hospitals, and nonprofit organizations, including government agencies-that are striving to serve as role models by applying for the Baldrige Award.

By becoming an examiner, you can make a major contribution to your own organization and to the national effort to recognize and promote performance excellence.

Click here for more information.

ISO Survey - Certifications Up Six Percent

The global market relevance of ISO’s management system standards for quality, environment, medical devices, food safety and information security reveals an increase in certificates of 6.23 %, a worldwide total of 1,457,912 certificates and users of one or more of the standards in 178 countries. The biggest increases in certification are to the sector-specific ISO 22000:2005 food safety management system standard which is up by 34 %and to the issue-specific ISO/IEC 27001:2005 information security management system standard which has risen by 21 %.

ISO Secretary-General Rob Steele comments, “Indicating nearly a million and a half users, these figures illustrate the continuing attraction of the ISO management system model pioneered by ISO 9001 for quality management and since extended to meet other challenges faced by public and private sector organizations.”

Training Courses

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ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Email: wtighe@sustainingedge.com

Phone: 888-572-9642 toll free

Website: http://www.sustainingedge.com

Houston Police Get ISO 9001-Certified

Walter — Tue, 27 Dec 2011 22:33:17 +0000

Our friends at the Phoenix Police Department’s Records and Identification Bureau were the first U.S. police department registered to the ISO 9001 standard back in 2003.

We just read that another police department, The Emergency Communications and Property Room Divisions of the Houston Police Department (HPD) was recently certified to ISO 9001:2008. HPD is the largest police department in Texas and the fifth largest in the United States. They pursued ISO 9001 certification, in part, because it establishes clear guidelines and goals against which they can measure achievements. Primarily, HPD determined that the ISO quality management system provides the ideal business model to further the Department’s commitment to continually improve its effectiveness in serving the needs of the community.

The Emergency Communications Division (ECD) is typically the first point of contact that the HPD has with the citizens of Houston. More than 1.2 million calls for service are dispatched by the ECD every year, which further include calls to utilize alternate response strategies. The process is designed so that 9-1-1 calls are initially received by a cadre of independent call takers who then distribute calls-for-service requests to the HPD or the fire department, accordingly.

A cultural shift

Countless improvements were realized in both divisions during the course of the QMS implementation. As stakeholders became more engaged and empowered, several time-saving ideas became evident and cost-savings were revealed. Creating process maps allowed everyone to actually see the sequence and flow of tasks and to identify nonvalue-added activity. This visual approach also made it possible to ensure process interconnectivity, or lack thereof.

There is a burgeoning interest in continuous improvement. With quantified performance improvement in virtually every work process, the incentive to sustain mutually beneficial supplier-customer relationships is now established.

Congratulations to another major police department achieving ISO 9001 success! Another example that certification success is obtainable for any organization; even ones that carry weapons. :)

ISO 19011:2011 Auditing Management Systems

Walter — Sun, 04 Dec 2011 19:21:08 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business December 2011

This Month

* ISO 19011:2011 Released

* Medical Device Regulations

* Issues Impact Global Conformance

* In the News

* Training Courses

Aerospace, Aviation and Defense Requirements Conference

January 25-26, 2012 Phoenix Convention Center Phoenix, AZ

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Happy Holidays!

We would like to thank all of you for being a part of our newsletter group. Your feedback and support makes us better, and we sincerely appreciate it. Thanks and the best to you in the New Year.

ISO 19011:2011 Just Released

ISO 19011:2011 2nd Edition dated 11/15/2011 has just been released. ISO 19011 provides guidance on auditing management systems, including the principles of auditing, managing an audit program and conducting management system audits. It also provides guidance on the evaluation of competence of individuals involved in the audit process, including the person managing the audit program, auditors and audit teams.

It is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit program. This includes small and medium-sized organizations, for both first party auditing (auditing your own company) and second party auditing (where customers audit their suppliers). It can be used for the purposes of self declaration, and can also be used for auditor training or personnel certification.

For third party auditing, users should also consider the use of ISO/IEC 17021:2011, “Conformity assessment – Requirements for bodies providing audit and certification of management systems.”

This edition reflects the need for a more generic guide for a wider range of auditing requirements, beyond covering just quality and environmental management systems standards. In this edition, remote auditing methods and the concept of risk management to systems auditing are introduced. The relationship between the document and ISO/IEC 17021 has been clarified. Confidentiality has been added as a new principle of auditing. A new Annex A gives illustrative examples of discipline-specific knowledge and skills. And additional information has been included in Annex B, resulting in the removal of help boxes.

The main body of ISO 19011:2011 establishes good practice for Managing an Audit Program and Performing an Audit. The update reflects current thinking and in parts is expanded significantly. These sections provide detailed guidance; intended to be used flexibly according to the size, level of maturity of an organization’s management system, and the nature and complexity of the organization to be audited. The concept of risk in auditing is introduced.

Some guidance will be provided on combined audits, where two or more management systems of different disciplines are audited together (for example QMS and EMS, EMS and OHSAS, QMS and OHSAS). Also, the use of technology in remote auditing is acknowledged.

Annex A (informative) of the standard provides examples of discipline specific knowledge and skills of auditors, including:

Transportation safety management
Environmental management
Quality management
Records management
Resilience, security, preparedness and continuity management
Information security
Occupational health and safety

The new ISO 19011:2011 replaces the previous edition ISO 19011:2002, as well as ISO 10011-1, ISO 10011-2, and ISO 10011-3. It was prepared by ISO Technical Committee 176, Subcommittee 3.

ISO 19011:2011 can be purchased here at the ANSI website.

2011 Guide to Medical Devices Regulations Released

If you’re a medical device provider and registered to the ISO 13485 Medical Device Quality Management System, it’s your job to know the FDA’s medical device regulations that apply to your organization and product inside out. But device regulations can be a moving target. Here’s a resource that can help keep them in your sights.

In its first revision in three years, the 2011 Guide to Medical Device Regulations is the most comprehensive, authoritative, up-to-the-minute guide to device regulations available anywhere. It includes full texts of every device-related regulation currently in force, plus executive summaries and analyses outlining their impact on companies like yours.

You’ll discover back-to-basics explanations of premarket submissions; user fees and how they work; guidance on inspection procedures and practices; reporting and tracking requirements; guidance on labeling; and FDA priorities for future regulatory initiatives.

The guide also features:

A comprehensive overview of the FDA’s regulatory framework for medical devices, from requirements to registering as a device maker to postmarket obligations.
A summary for each of the 65 device-related guidance documents included in the guide.
A rundown on the Center for Devices and Radiological Health’s future plans for its medical-device regulation system.

Already the Center for Devices and Radiological Health has revealed plans to strengthen premarket review, enhance data collection, improve tracking of devices and adverse events, harmonize standards with other nations, and share inspections data with foreign regulators.

Failure to heed FDA regulations is a sure path to refusals, 483s, and warning letters, not to mention liability lawsuits that could bankrupt a company.

The 2011 Guide to Medical Device Regulations is available in print or PDF formats. The guide can be purchased on the FDA website.

ANSI: Key Issues Impacting Global Standardization and Conformance

The American National Standards Institute (ANSI) International Policy Committee (IPC) has published a white paper examining standards and conformance issues affecting the ability of U.S. industry to conduct global trade. The IPC is responsible for the development of ANSI strategic directions and policies related to international and regional standardization, as well as the general coordination and oversight of ANSI’s implementation of the relevant initiatives of the United States Standards Strategy (USSS).

According to the paper “Key Issues Impacting Global Standardization and Conformance: Today and Tomorrow,” the expansion of global trade is increasingly important to the growth of the U.S. economy and the continued revitalization of the U.S. workforce. As the technical underpinning of many products and services, standards play a critical role in removing barriers to trade, enforcing free trade agreements, and expanding foreign markets for U.S. products, services, and personnel.

The paper contends that U.S. companies that do business abroad are exposed to-and typically adopt-internationally accepted standards and conformity assessment practices, which in turn enable them to compete more effectively in the global marketplace. The paper identifies that one in every five American factory workers owes his or her job to exports. Agreed-upon standards and conformance activities form the basis of dynamic, global strategic partnerships that can spur economic growth, development, and job creation.

Particularly in emerging technology areas-including smart grid, health-care informatics, energy efficiency, nanotechnology, and cyber-security-developing and developed economies are playing an increasingly significant role in standardization activities. According to the white paper, these priority areas require significant cross-sectoral collaboration, and new models of standards development must evolve to support such collaboration. The challenge for today and into the future is to bring diverse parties from various sectors and organizations together to collaborate and develop the needed deliverables.

In the News

Four Organizations Awarded 2011 Baldrige NQA Award

U.S. Commerce Secretary John Bryson announced four organizations-three health care operations and one nonprofit business-as the recipients of the 2011 Malcolm Baldrige National Quality Award, the nation’s highest honor for performance excellence through innovation, improvement, and visionary leadership. This marks the first year that three health care organizations have been selected at one time.

The Baldrige Performance Excellence Program (BPEP) not only manages the Malcolm Baldrige National Quality Award, it also raises awareness about the importance of performance excellence in driving the U.S. and global economy; provides organizational assessment tools and criteria; educates leaders in businesses, schools, health care organizations, and government and nonprofit organizations about the practices of national role models; and recognizes them by honoring them with the only presidential award for performance excellence.

For more information, visit the NIST website.

ISO Management Systems Standards for Records

In the wake of recent failures in corporate governance, two new standards from the International Organization for Standardization (ISO) will help organizations to disclose corporate information quickly and effectively. Increased pressure by industry regulators obliges companies to provide such information because irregularities in financial management, ethical dealings, disclosure, and transparency of decisions have become common.

ISO 30300:2011-”Information and documentation-Management systems for records-Fundamentals and vocabulary,” and ISO 30301:2011-”Information and documentation-Management systems for records-Requirements,” distill the expertise of experts drawn from 27 countries on five continents.

“The ISO 30300 series offers the methodology for a systematic approach to the creation and management of records, aligned with organizational objectives and strategies,” say Judith Ellis and Carlota Bustelo, leaders of the working groups that developed the standards. “Managing records using an MSS supports cost-effective operational processes, such as storage, information retrieval, information reuse, litigation, and due diligence.”

The ISO 30300 series can be purchased through the ISO Store.

Training Courses

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ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Email: wtighe@sustainingedge.com

Phone: 888-572-9642 toll free

Website: http://www.sustainingedge.com

Four Organizations Awarded 2011 Baldrige National Quality Award

Walter — Sat, 26 Nov 2011 19:07:44 +0000

U.S. Commerce Secretary John Bryson announced four organizations—three health care operations and one nonprofit business—as the recipients of the 2011 Malcolm Baldrige National Quality Award, the nation’s highest honor for performance excellence through innovation, improvement, and visionary leadership. This marks the first year that three health care organizations have been selected at one time.

The 2011 Baldrige Award recipients—listed with their category—are:

• Concordia Publishing House, St. Louis, Missouri (nonprofit)

• Henry Ford Health System, Detroit, Michigan (health care)

• Schneck Medical Center, Seymour, Indiana (health care)

• Southcentral Foundation, Anchorage, Alaska (health care)

The 2011 Baldrige Award recipients were selected from a field of 69 applicants. All of the applicants were evaluated rigorously by an independent board of examiners in seven areas defined by the Baldrige Criteria for Performance Excellence: leadership; strategic planning; customer focus; measurement, analysis, and knowledge management; workforce focus; operations focus; and results. The evaluation process for each of the recipients included about 1,000 hours of review and an on-site visit by a team of examiners to clarify questions and verify information in the applications.

Named after Malcolm Baldrige, the 26th Secretary of Commerce, the Baldrige Award was established by Congress in 1987 to enhance the competitiveness and performance of U.S. businesses. The award promotes excellence in organizational performance, recognizes the achievements and results of U.S. organizations, and publicizes successful performance strategies. The award is not given for specific products or services. Since 1988, 90 organizations have received Baldrige Awards.

For more information, go to www.nist.gov/baldrige.

Celebrate World Quality Month

Walter — Wed, 02 Nov 2011 00:15:50 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business November 2011

This Month

* Celebrate World Quality Month!

* Lean Six Sigma Reduces Debt

* Special Processes

* In the News

* Training Courses

2012 ASQ

Lean Six Sigma Conference

February 27-28th Phoenix, AZ - Join us there!

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If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Celebrate World Quality Month!

In celebration of the World Quality Month in November, the American Society of Quality will showcase how advancements and valuable quality contributions have improved incomes for businesses, communities, and institutions worldwide. During World Quality Month, ASQ recognizes the quality contributions of its global membership and World Partner organizations, and shares quality tools and techniques with the quality community.

“Through World Quality Month, we continue to raise the voice of quality by celebrating quality successes throughout the world,” said Paul Borawski, ASQ CEO. “In addition, World Quality Month will raise awareness of the important role quality plays in our personal and professional lives.”

In conjunction with World Quality Month, ASQ has launched WorldQualityMonth.org, a website dedicated to people passionate about quality – highlighting quality tools and techniques, quality success stories, and World Quality Month events.

Visitors can visit 7 different websites with special events going on in the month of November. Read on the websites what executive leaders are saying about the state of quality, and learn about the many organizations from around the world celebrating World Quality Month with ASQ.

Aligned with World Quality Month we want to share with our readers a recent survey that was conducted with the Malcolm Baldrige National Quality Award Examiners which provides some interesting insight into current perceptions of performance.

Management and nonmanagement personnel across a broad cross-section of U.S. organizations see eye to eye on mission, customer focus, and commitment to success but differ significantly in their views on how to best measure quality of work and customer satisfaction. These are a few of the findings from a recent survey of nearly 500 members of the 2011 Board of Examiners for the Malcolm Baldrige National Quality Award.

Baldrige examiners are experts from industry, educational institutions, health care providers, government at all levels, and nonprofit organizations who volunteer many hours reviewing applications for the award, conducting site visits, and providing each applicant with an extensive feedback report citing strengths and opportunities to improve.

The Baldrige Performance Excellence Program asked this year’s examiners to assess their own organizations using either the program’s “Are We Making Progress?” or “Are We Making Progress as Leaders?” questionnaires, depending on whether or not the examiners worked in management.

These survey tools are based on the Baldrige Criteria for Performance Excellence and allow an organization to gauge its progress in achieving high performance and define where improvements are needed to reach that goal.

The 173 employees and 294 leaders taking the surveys were in strong and positive agreement, regardless of institution, on a number of factors, including understanding of the organization’s mission, clear identification of most important customers, and strong commitment to success. Both groups also matched up on areas where they perceived that the organization was not performing well, such as actively seeking input for long-range planning, using good processes to perform tasks, and removing obstacles in the way of progress.

Perhaps most interesting were the areas where employees and leaders differed significantly in their perceptions. These included knowing how to measure work quality (78% of employees felt they had such knowledge while only 51% of leaders agreed that they did), using work quality measures to make improvements (74% of employees said that they did, while only 43% of leaders recognized that ability), and feeling that customers were satisfied with work performed (85% of employees felt their work achieved this status while just 69% of leaders agreed). The one statement with a large response discrepancy where the leaders agreed more than the employees-84 percent to 69 percent-was “My boss and my organization care about me.”

“The survey results indicate a lot of opportunity exists for better communication between leaders and employees, as well as improving performance measurement and overall organizational performance,” says Harry Hertz, director of the Baldrige Performance Excellence Program.

To see the complete results of the 2011 Examiners Survey, click here for the employee responses, and here for those of the leaders. Both sites also include results from an earlier survey of examiners to compare and contrast current perceptions of performance with those in the past.

Lean Six Sigma Reduces Debt - But faces Obstacles

Speaking of Surveys – We recently joined in a survey with more 2,500 quality professionals on how Lean Six Sigma could help reduce the soaring national debt but faces some key challenges in government implementations, The biggest obstacle, survey respondents said, is a U.S. federal government structure that can be a barrier to comprehensive evaluation and accountability.

Lean Six Sigma in Action

Many of the survey participants say there are benefits to using Lean Six Sigma. More than 75 percent of participants surveyed said they have implemented Lean Six Sigma in their organizations; 79 percent said the tool is very effective in improving efficiency and productivity.

The respondents found that Lean Six Sigma has also been effective in the following areas:

Raised levels of quality in their organization (74 percent).
Reduced costs (73 percent).
Helped individuals in their organization be competitive in the marketplace or to pursue the organization’s core mission (68 percent).
Had a positive impact on employee safety (56 percent).
Improved innovation (46 percent).

“There are true benefits to using lean and Six Sigma to reduce the national debt, but it’s important to emphasize that these tools alone are not a solution for all government budget ailments,” said Liz Keim, ASQ Past President and Lean Six Sigma expert. “There are a number of other excellent quality improvement methods available, and it is crucial to match the right tool with specific needs.”

While applied for a long time in most types of manufacturing and service sectors, these management methods have only been more recently used by the federal government. Lean emphasizes removing waste from organizations and processes while focusing on and delivering more value to customers. Six Sigma focuses on variation reduction in processes, products, and services.

Special Processes

Some organizations are unsure if ISO 9001:2008, clause 7.5.2, is applicable to their quality management system. For a production process, if its resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies only become apparent after the product is in use, the process must be validated. The Aviation, Space and Defense Standard Standard, AS9100:2009, clause 7.5.2, states in a Note that these processes are often referred to as “special processes”.

The Aviation, Space and Defense Standard on audit requirements, AS9101:2010, states in clause 4.2.2.8, that when special processes are identified in the audit plan, the audit team must evaluate the process validation, as well as, the monitoring, measuring, and control of these processes.

To verify the validation of special processes, the process records must be reviewed for each audited special process, including a comparison of the actual and planned results.

To verify the monitoring, measurement, and control of special processes, the audit team must identify the process requirements, including customer requirements, for the special processes. For the sampled processes, the audit team must assess the monitoring and measuring equipment used (e.g., calibration, accuracy) and the method for recording results. If required, the traceability between the process (e.g., batch or load charge identification) and the resulting products are to be verified.

For outsourced special processes, the audit team must verify the organization’s supplier control process addresses these items. In addition, the audit team must review the use of customer-designated sources, as required. Keep in mind if you outsource special processes, ensure you receive the proper information, for example a certification or other source.

AS9101:2010 includes a Note that states special processes are managed by using personnel qualified as required by the organization and/or customer requirements, and by controlling physical or chemical process characteristics, e.g., temperature, time (process duration), pressure, chemical composition of product or process treatment material (surface treatment solution).

In the News

Baldrige Award Hospitals Outperform Peers

More than two-thirds of owner-reported, new-vehicle interior problems are design-related issues rather than defects or malfunctions, according to the J.D. Power and Associates 2011 U.S. Interior Quality and Satisfaction Study. The study is based on responses from more than 73,000 new-vehicle owners who purchased a 2011 model-year vehicle. The study was fielded between February and May 2011.

Health care organizations have accounted for more than 50 percent of Baldrige award applicants since 2005.

Click here for a PDF of this comprehensive important study.

What do Black Belt’s do?

So what do you do? This one is for every Black Belt who has grimaced when answering the seemingly innocent question posed by a new acquaintance. Try this: “I’m a senior executive statistical analysis technician. I catenate diverse statistical information and maximize potential utilization of data.” My job’s not about output, it’s about throughput.”

Watch this short clip from that 70′s Show.

Translating Customer Satisfaction to Financial Results Study

A 2010 survey done by The Center for Hospitality Research at Cornell University focused on hotel guests’ satisfaction and the relationship to financial performance.

The survey cited four key performance indicators that influenced guests’ evaluations.

1. Reservation was accurate.
2. Check-in was completed within five minutes.
3. No problems were experienced during the stay.
4. No billing errors occurred.

Find out more by downloading the Cornell PDF Report.

Training Courses

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ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Email: wtighe@sustainingedge.com

Phone: 888-572-9642 toll free

Website: http://www.sustainingedge.com

Economic Benefits of Standards – Case Studies

Walter — Sun, 16 Oct 2011 22:05:59 +0000

A series of groundbreaking case studies by the International Organization for Standardization (ISO) and partner organizations shows that implementing standards can provide economic benefits from between 0.5 and 4 percent of companies’ annual sales revenues. The studies are based on the experiences of 11 companies operating in a variety of business sectors in 10 countries.

The size of the companies varies from a small business with 25 employees and annual sales revenue of around $4.5 million, to companies with several thousand employees and annual revenue of more than $1.5 billion. They operate in a variety of business sectors: agri-food, chemicals, construction and construction materials, electrical appliances, electrical power transmission, food retail/food logistics, industrial automation equipment, and information and telecommunications.

These case studies were undertaken in close cooperation between an ISO member body, an academic institution, a company in the respective country, and staff of the ISO Central Secretariat acting as advisors to the project team.

Readers interested in more details of the preliminary case studies can find the full versions of the reports originally developed by the project teams and summary presentations about each project at the iso.org website.

Interested in more information on the proven financial benefits of ISO Registration, contact us. Share with us your organization’s benefits derived from registration. These benefits are much more than financial. Let us know and we will publish your comments in our next monthly newsletter!

Common Myths of Management Systems

Walter — Mon, 03 Oct 2011 03:13:55 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business October 2011

This Month

* Common Myths of Management Systems

* ISO Publishes 6 Sigma Method

* Outsourcing Strategies

* In the News

* Training Courses

Arizona BioScience

Awards Dinner and EXPO October 13-14, 2011 Phoenix – See you there!

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If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Common Myths of Management Systems

A recent article written by Mark Ames and team discusses the many myths and misunderstandings related to the implementation of management system standards such as ISO 9001. Belief in these myths is the most common barrier to the use of management system standards and, in addition, the greatest cause of frustration and diminished benefits on the part of users.

Understanding these myths can help organizations choose to adopt a management system and ultimately achieve the intended benefits embedded within all management system standards. The purpose of the article is to identify and debunk the most common myths surrounding management system standards.

Management systems don’t add value but I have to have one because my customers want me to have one.

Management systems provide bottom-line cost savings and improved profitability and performance through embedded preventive practices. Organizations of any size performing activities of any kind that are considering adopting a management system standard can expect to see increased value to customers and greater return on investment through appropriate discipline and communication.

Points to consider

Management systems help organizations avoid mistakes and save resources, time, and money.
Organizations that are not achieving value from their management systems may not be clear on their true purpose and may be just going through the motions.
Excessive documentation can and will reduce the management system’s value to the organization and its customers and should be considered counterproductive.

Management systems are a net cost to my organization

Studies have shown (example – article in our September issue) that preventing a problem is less expensive-and in many cases much less expensive-than dealing with the consequences after a problem occurs. If an organization implements a management system standard and its net cost increases, the organization needs to examine and reconsider its approach to implementing the management system.

Points to consider

Excessive costs associated with management systems often come from an organization’s failure to take ownership of the completed management system. This is particularly true if there is a lack of ownership on the part of top management.
If you create a system that you are unwilling to work with on a daily basis, it will provide little or no value, and, in fact, may be a net cost to the organization.

Management system standards do not allow my organization to be flexible and innovative

During management system implementation, the organization will need to make decisions that allow it to remain flexible where flexibility is important, while at the same time providing enough structure to ensure good discipline where discipline is needed.

Point to consider

Management systems are written in a way that serves any organization. If an organization has an inflexible management system that ties the organizations hands, it is because the management system was created that way. Careful decisions are required to balance the need for discipline and structure on one hand and the need for flexibility on the other.

Management system certification is not required; therefore, my organization doesn’t need it

Management system standards contain a collection of best practices that have evolved over the last 200 years. Management systems provide a pragmatic, systematic methodology for organizations, helping them achieve results for themselves and their customers. Certification of a management system by an internationally recognized accreditation body (such as the ANSI-ASQ National Accreditation Board-ANAB) will verify the successful adoption of the imbedded preventive practices and will foster confidence in customers and stakeholders.

Points to consider

Management systems provide a clear path and associated transparency related to an organization’s methods, measurements, and results, thus providing confidence in the organization’s ability to meet both customer and legal requirements. It is likely that management system standards will become increasingly important in the future because they provide:

A proactive methodology for meeting legal, regulatory and other related obligations.
Internal financial and other benefits associated with the preventive practices embedded in each management system standard.
Benefits to customers, stakeholders, and the broader marketplace that is communicated when the certification is issued by a certification body accredited by an internationally recognized accreditation body.

Management system standards do not guarantee product quality

Nothing can absolutely guarantee product quality. However, management systems can go a long way toward preventing problems from occurring in the first place, thus providing dramatic improvements in results while reducing costs.

Points to consider

While management systems do not assure absolute results, the preventive steps embedded in management systems will dramatically increase the likelihood of consistent product and overall business success.
Management systems do create a monitoring and measurement system of processes and products, or services that substantially increase your ability to produce consistent quality

What your organization should not do

Your organization should not implement a management system and associated procedures just because they have been developed and successfully used by another organization. No two organizations do things in exactly the same manner. What works for one organization will not achieve the same success for another.

The worst-case scenario is that you use and implement a documented management system that another organization has used. This system does not represent your organization, its language, or how you deliver your products and services. This type of method will only confuse your personnel and decrease its purpose and value; including increasing your operating costs.

Conclusion

Put simply, management systems prevent problems. They work efficiently and effectively whenever organizations can get past the myths addressed in this article. A clear understanding that the end result may be a fundamental change in how the business operates will help organizations make the transition from reactive management to preventive management. Use of management systems standards and the associated accredited certification process should reduce costs, improve results, improve customer satisfaction and provide confidence to customers, stakeholders, and organizations.

For all your organizational management system needs, please contact us.

ISO Publishes Six Sigma Improvement Methodology

Six Sigma is a data-driven method for improving business and quality performance, has been published as a two-part ISO standard.

Six Sigma was originally developed by Motorola in 1986 to ameliorate manufacturing processes with the goal of products free of defects (i.e., 3.4 errors per million). Today, the methodology is applied in many sectors of activity by organizations large and small for all types of process and services to:

Drive process improvement and make statistically based decisions
Measure business results with a level of reliance
Prepare for uncertainty
Combine high returns and benefits in the short, medium and long-term
Remove waste, defects and errors.

Although Six Sigma has existed for some time, bringing its best practice together under an ISO standard helps solidify and consolidate the methodology. The ISO brand is respected and recognized worldwide, and thus provides an added layer of confidence. Moreover, publication of Six Sigma methodology in an ISO standard will boost international uptake of the methodology in a coherent form, reduce fragmentation, and provide users with harmonized best practice,” concluded Dr. Boulanger, President of JISC-Statistics and co-chair of the subcommittee that developed the standard.

The new standard, ISO 13053:2011, Quantitative methods in process improvement – Six Sigma, deals exclusively with the application of Six Sigma to ameliorate existing processes and is published in the following two parts:

Part 1: DMAIC methodology, describes the five-phased methodology DMAIC (Define, Measure, Analyze, Improve and Control), and recommends best practice, including on the roles, expertise and training of personnel involved in such projects.
Part 2: Tools and techniques, describes tools and techniques, illustrated by factsheets, to be used at each phase of the DMAIC approach.

Both documents can be applied to all sectors and organizations. You can purchase the standard by your country through the ISO Website.

Outsourcing Strategies

The third annual survey of providers of offshore labor is part of ongoing research into the effects of offshoring trends on the economy and reflects changes in the provision and consumption of global sourcing in recent years.

Offshoring Research Network and Duke University’s Fuqua School of Business surveyed 620 service providers at 1,850 companies from more than 50 countries and found that a shift in the outsourcing industry is affecting incumbent India-based and U.S. firms. These are caught in a “perfect storm” in which new outsourcing competitors are entering new markets to offer both low-end, commoditized services with few market-entry barriers, and high-end, value-added services that drive higher margins where market entry is more challenging.

As noted in the survey, the importance of workforce skills and training has increased since 2009, becoming the most vital criteria in a client’s decision making when choosing between a selection of service providers. Companies are planning to make aggressive investments in training centers for internal staff-especially in functions involving a high level of client-specific knowledge and frequent interaction with clients, such as research and development and design services-enabling them to get closer to the client’s core competencies.

“The global sourcing industry is undergoing significant changes,” says Arie Lewin, professor of strategy and international business at Fuqua and director of CIBER. “Clients expect providers to contribute value beyond just cost savings. Global sourcing is becoming more competitive all the time. Service providers now must offer more than just cost savings; they must add value to their clients’ business processes.”

The survey also found more than 56 percent of outsourced labor providers plan to invest in new areas of expertise, with a primary focus on cloud or service-oriented architecture aimed at integrating disparate web applications, and centers of excellence teams promoting collaboration and best practices. In addition, 74 percent of service providers plan to continue expanding the scale and scope of their services; mergers and acquisitions account for 13 percent of planned growth during the next three years, with 13 percent of service providers indicating a desire to become an acquisition target.

View a PDF detailed report of the survey.

In the News

Vehicle Quality Issues Due to Design

Design-related interior problems can have a considerable negative impact on overall interior satisfaction. For example, satisfaction averages 8.1 on a 10-point scale among owners who report no interior design problems, but drops to 7.2 when at least one interior design problem is reported. Of the top five most frequently reported problems within the interior, all five are design-related: material scuffs and soils easily; cruise control difficult to use or is in a poor location; cup holders difficult to use; center console difficult to use; and door locks difficult to use or controls are in a poor location. Problems related to the center console have increased from 2010.

ASQ Contest To Raise The Voice of Quality

The American Society for Quality (ASQ), the global voice of quality, is gearing up for the 2011 World Quality Month celebration in November with the launch this week of the YouQ video contest-asking people passionate about quality to show how quality tools have made a positive impact in their workplaces and communities.

Participants can upload their videos through Oct. 31, 2011, on ASQ’s Facebook page. Individual and team submissions, as well as submissions from throughout the world, are encouraged. The contest is designed to raise the voice of quality, strengthen connections within the global quality community, and showcase the impact of quality worldwide. The contest will help participants share quality insights and ideas, and present new solutions to challenges.

Viewers who “like” ASQ on Facebook will vote on videos and select the winners during World Quality Month, an annual celebration of quality and its impact on the world. Winners of the YouQ video contest will be announced in December. Prizes for the YouQ video contest include an Apple iPad 2 with Wi-Fi and 3G, and a 64GB iPod Touch.

For more information about the YouQ video contest, visit ASQ Facebook Page.

Training Courses

View all our Courses

View Our Web Based E-Training Courses

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

Email: wtighe@sustainingedge.com

Phone: 888-572-9642 toll free

Website: http://www.sustainingedge.com

Evidence of Management Systems Standards Value

Walter — Thu, 01 Sep 2011 14:52:11 +0000

Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business September 2011

This Month

* Evidence of Management Systems Value

* New ISO 27005 Standard Improves ISMS

* Special Processes Requirements

* In the News

* New Service Management Standard

* Training Courses

Arizona BioScience

Awards Dinner and EXPO October 13-14, 2011 Phoenix – See you there!

Quick Links…

Join Our Newsletter List!

Connect With Us

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Evidence of Why Management Systems Standards Add Value

Quality Digest Magazine published a two-part article in August describing how implementing management systems and attaining third-party accredited certification can help businesses achieve success on many fronts. The article title – “It’s official: Companies get more revenue from using standards than they cost to implement.“

For many years, various media have discussed anecdotal information concerning the value of third-party accredited certification to management systems. Sound, documented evidence from academic studies now confirms the value of third-party accredited certification of management systems.

The most noteworthy studies about management system standards in the last 20 years have dealt with the two most popular standards: ISO 9001 (quality management systems) and ISO 14001 (environmental management systems). Most articles on this topic have been positive, but not many have been based on hard data. We’ve now reached the time to clearly communicate the data associated with the benefits of adopting management system standards.

Here are a few conclusions of recent studies (additional benefits and the specific data will follow):

Management systems standards return a bottom-line financial value larger than any investment or time incurred.
Adopters of management system standards have higher rates of corporate survival than non-adopters.Adopters of management system standards have higher sales than non-adopters.
Small businesses achieve proportionally more benefits than larger organizations.

A 2008-2010 detailed study published by the Harvard Business School provides real data, gathered by external means, which emphasize the value of management system standards and the accredited certification process. The study documents compelling evidence regarding standards from the International Organization for Standardization (ISO) stating that “ISO adopters have higher rates of corporate survival, sales, employment growth, and wage increases than a matched group of non-adopters.” The study also finds that “annual earnings per employee grew substantially more rapidly, post-ISO certification, than organizations that did not adopt ISO.”

The study demonstrates broad and unexpected improvements from adoption of and certification to management system standards, derived from a matched sample of nearly 1,000 ISO 9001 adopters, as compared with non-adopters.

Organizations that adopt and certify to the quality management systems standard, ISO 9001, improved corporate survival and profit. The Harvard study indicates sales increases of nearly 9 percent after certification, as compared with non-adopters. Adopters also had a 10-percent higher increase in the number of employees than non-adopters while at the same time increasing profit. Total payroll in firms certified to ISO management systems standards grew 17.7 percent more than non-adopters. ISO 9001 adoption required a higher level of employee competence. The data shows an annual wage increase for the workers of 7.7 percent.

Conclusions from a 2007 Wharton Risk Management and Decision Processes Center study relate to the adoption of and certification to ISO 14001, the environmental management systems standard. Organizations were much more likely to achieve performance gains from ISO 14001 certification when they targeted a specific environmental aspect:

96.7 percent of respondents indicated a reduction in waste,
90.0 percent indicated a reduction in environmental incidents98.3 percent indicated an improvement in emergency preparedness,
96.5 percent indicated a contribution to improved environmental performance of their product.

The Wharton publication also highlighted the range of costs and savings associated with the implementation of ISO 14001. For example, 65 percent of facilities that estimated their first-year cost savings indicated savings of up to $25,000, with 27 percent reporting savings of up to $100,000. Another 57 percent estimated maximum continued savings of up to $25,000 annually, while 28 percent reported savings of up to $100,000 annually, and 15 percent reported savings of more than $100,000 annually. Some 40 percent found a very high correlation between ISO 14001 certification and easier relationships with the government and a more positive perception by the public.

Points to consider from these studies include:

Management systems standards provide benefits across a broad front and affect all stakeholders, business owners, and employees.
Management system certification is not just for large organizations. In fact, benefits to small organizations outpace those achieved by larger organizations.
Development and use of management systems standards is expanding.Proven benefits to organizations, customers, and other stakeholders drive expansion and use of management systems.
Management systems deliver results.

The conclusions are clear: Certification to management systems results in benefits to the organization and its employees; businesses become more profitable, and they pay their employees more. The Harvard study also indicates that “the benefits achieved with implementation of ISO 9001 were statistically higher in smaller organizations than in larger organizations.”

Read the Quality Digest full article. For all your ISO 9001 and 14001 EMS needs, Contact Us.

New ISO/IEC 27005 Standard Improves Protection

Information security risks pose a considerable threat to businesses due to the possibility of financial loss or damage, loss of essential network services, or loss of reputation and customer confidence. Risk management is one of the key elements in preventing online fraud, identity theft, damage to Web sites, loss of personal data and many other information security incidents. Without a solid risk management framework, organizations expose themselves to many types of cyber threats.

The International Standard ISO/IEC 27005:2011 gives managers and staff in IT departments a framework for implementing a risk management approach to assist them in managing their information security management system (ISMS) risks.

It describes the information security risk management process and associated actions, and supports the general concepts specified in ISO/IEC 27001:2005,Information technology – Security techniques – Information security management systems – Requirements.

Knowledge of the concepts, models, processes and terminologies described in ISO/IEC 27001 and ISO/IEC 27002: 2005, Information technology – Security techniques – Code of practice for information security management, is important for a complete understanding of this International Standard. The information security risk management process consists of:

Context establishment
Risk assessment
Risk treatment
Risk acceptance
Risk communication, and
Risk monitoring and review.

However, ISO/IEC 27005:2011 does not provide any specific methodology for information security risk management but a generic approach. It is up to the organization to define its approach to risk management, depending, for example, on the scope of the information security management system, based on the context of risk management, or the industry sector.

Purchase ISO/IEC 27005:2011 at the ISO Website.

Special Processes Requirements

Some organizations are unsure if ISO 9001:2008, and AS9100:2009 clause 7.5.2, is applicable to their quality management system. For a production process, if its resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies only become apparent after the product or service is in use, the process must be validated.

To verify the validation of special processes, the process records must be reviewed for each audited special process, including a comparison of the actual and planned results.

For outsourced special processes, the audit team must verify the organization’s supplier control process addresses these items. In addition, the audit team must review the use of customer-designated sources, as required. This means that if you outsource any special processes, you must identify those and ensure you receive the proper documentation or certification for validation. Your purchasing processes can be used to identify the controls necessary.

If you are interested in training for ISO 9001:2008, or aerospace industry sector schemes based on AS9100 series, click on our courses in this newsletter below.

In the News

AS9100C Blog from SAI Global

SAI Global, a Certification Body (CB) has announced a new blog for the aerospace AS9100 sector. SAI Global traditionally aims to offer the best customer experience and valuable knowledge. The AS9100 blog is intended to provide aerospace professionals with recent industry updates, expert tips, new documents released, engaging case studies, and advice. SAI Global’s product manager and industry technical expert for AS9100-series of standards, Roger Ritterbeck, manages the blog and is ready to answer any questions or concerns.

Pharmaceutical QMS Auditor Certification

The International Register of Certificated Auditors (IRCA) has launched a new Pharmaceutical Quality Management Systems (PQMS) Auditor certification scheme (ICH Q10), to support the assurance of global supply-chain integrity.

Within this context the IRCA PQMS Auditor certification scheme is designed to provide confidence that auditors in the pharmaceutical and biotech industries have the training and experience required to provide an accurate assessment of organizations’ ongoing capability to deliver products that meet the requirements of patients, health care professionals, regulatory authorities, and internal and external customers throughout the product life cycle.

View more information about certification as a PQMS auditor.

ISO 27001/IEC 20000-1:2011 Service Management

ISO/IEC 20000-1:2011 Service Management System Requirements, has been issued as the new 2nd Edition. The new revision specifies requirements for a service provider to plan, establish, implement, operate, monitor, review, maintain and improve a service management system (SMS). The requirements include the design, transition, delivery and improvement of services to fulfill agreed service requirements.

The types of companies that may find this standard helpful are:

organizations seeking services from service providers and requiring assurance that their service requirements will be fulfilled;
organizations requiring a consistent approach by all service providers, including those in a supply chain;
service providers intending to demonstrate capability for the design, transition, delivery and improvement of services that fulfill service requirements;
service providers needing to monitor, measure and review service management processes and services;
service providers wishing to improve the design, transition, delivery and improvement of services through the effective implementation and operation of the SMS;

This is another standard that reflects the growing trend towards the development of management standards, aimed at providing a framework for business management processes.

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